Forbes Contributor Prescribes Important Changes to Improve Information Sharing in Our Healthcare System
Open Dialogue between Healthcare Professionals and Biopharmaceutical Companies Would Benefit Patients
07.16.14 | By Jeff Francer
Continuing an important conversation about how to make the best use of the wealth of information regarding today’s healthcare treatment options, last week Nicole Fisher wrote in Forbes about the growing need for a new regulatory paradigm to govern how the biopharmaceutical industry communicates with healthcare professionals about medicines.
Physicians and other healthcare providers require the most accurate and complete information regarding medicines in order to make informed decisions about treatment options for their patients. The Food and Drug Administration (FDA) prohibits biopharmaceutical companies from proactively sharing information not contained within a medicine’s approved labeling, even if the information was submitted to the Agency as part of the drug review process. This information may include health economic information, "real-world evidence" of safety and effectiveness based on health records, or even data about how a medicine impacts specific sub-populations of patients, such as gender or age cohorts, in the clinical trials, which could be useful for treating physicians.
As Fisher points out, “many drugs may be effective in treating disease states or patient populations outside their FDA-approved indications.” In fact, prescribing medicines for non-primary uses is a widely accepted practice in the American medical community. Fisher notes, “According to a 2006 Stanford study, an estimated 21% of all written prescriptions are for non-primary label use.” Thus, physicians should have ready access to information about such uses in order to best treat patients.
Fisher also sees the accumulation of unregulated content across the web as an important reason for a change in FDA policy: “Today’s patient has far better tools to become informed about the prescription drugs available to them. The proliferation of information publicly available on the internet has left the FDA racing to issue guidance for the monitoring of interactive media and flooding federal websites with new data sets every month.” Unregulated entities can post anything online about prescription medicines, while the FDA continues to limit regulated biopharmaceutical companies from providing scientifically accurate information about the products they research, develop and manufacture to improve patient health.
Some progress on this issue has been made in the courts. In 2012, a U.S. Circuit Court of Appeals ruled that pharmaceutical companies and their representatives have the constitutional right to provide truthful and non-misleading information about medicines, even if the information is not contained in the approved labeling. Such information could be used by treating physicians to improve patient care.
Our health care system is best served by an open dialogue between healthcare providers and biopharmaceutical companies to ensure that physicians have access to the most accurate and complete information to meet patients’ needs.